Senior Regulatory Affairs Specialist
2 tygodni temu
Senior Regulatory Specialist, CTA/IND
We are seeking a highly skilled Senior Regulatory Specialist to join our Polish Hub. This role will be responsible for coordinating, developing, and refining the CTA/IND lifecycle strategy, ensuring timely content delivery and compliance with GSK policy and procedures.
Key Responsibilities:
- Develop and implement the CTA/IND lifecycle strategy, ensuring compliance with regulatory requirements and GSK policies.
- Coordinate with cross-functional teams to ensure timely content delivery and submission to regulatory agencies.
- Accountable for ensuring the quality of work and delivery of projects to agreed timeframes.
- Provide input to internal processes and written standards.
- Work flexibly to meet shifting priorities and timelines.
Requirements:
- Min. Bachelor's degree in biological or healthcare science.
- Relevant experience within Regulatory Affairs in the R&D, pharmaceutical industry or clinical trials.
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Excellent organizational skills, attention to detail, and commitment to deliver high-quality output.
- Ability to work in multiple IT systems and lead in a matrix environment.
What We Offer:
- Contract of employment.
- Hybrid work (2/3 days per week from the office).
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).
- Life insurance and pension plan.
- Private medical package with additional preventive healthcare services for employees and their eligible.
- Sports cards (Multisport).
- Possibilities of development within the role and company's structure.
- Personalized learning approach (internal trainings, mentoring, access to online training' platforms).
- Extensive support of work-life balance (flexible working solutions, short Fridays option, health & well-being activities).
- Supportive community and integration events.
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